DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/02/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 02/02/2026 (“Amendment”). Claims 11-20 are currently under consideration. The Office acknowledges the amendments to claim 11. Claims 1-10 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 11-20 are directed to a “system,” which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 11 recites (“sets forth” or “describes”) the abstract ideas of a mathematical concept, substantially as follows:
fitting the EEG data to a state space model to produce a fitted state space model, wherein fitting the EEG data to the state space model comprises fitting to at least one oscillatory component and iteratively expanding the state space model by adding additional oscillatory components until an information criterion indicates a best fit state space model; estimating at least one value of cross-frequency coupling of the EEG data using the fitted state space model; and generating a report in real time including information related to a current state of consciousness of the patient based on the at least one value of cross-frequency coupling.
The fitting, estimating, and generating steps involve the mathematical concepts of comparison, model evaluation and selection, and calculation (i.e., fitting data to a model, selecting one, and performing a calculation based thereon). These steps correspond to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claim 11 does not include additional elements that integrate the mathematical concept into a practical application. Therefore, the claims are “directed to” the mathematical concept. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. a processor for carrying out processing/calculating steps), and
add insignificant extra-solution activity (the pre-solution activity of: receiving EEG data, using generic data-gathering components (e.g. a plurality of sensors); and the post-solution activity of: displaying a report, using generic data-outputting components (e.g. a display)).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the display of the report does not necessarily realize a diagnostic benefit as nobody needs to see or act on the report. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claim 11 does not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. estimating phase amplitude modulation between specific wave components (claims 12-14), estimating a correlation value (claim 15), fitting harmonic frequencies (claim 16), modeling based on an alpha component and Von Mises prior (claims 17 and 18), and modeling based on damping factor and a beta distribution (claims 19 and 20), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2014/0187973 (“Brown’973”) in view of US Patent Application Publication 2016/0242690 (“Principe”).
Regarding claim 11, Brown’973 teaches [a] system for estimating at least one oscillatory component of a patient brain state while the patient is receiving at least one drug having anesthetic properties (Abstract), the system comprising: a plurality of sensors configured to receive electroencephalogram (EEG) data from the patient while the patient is receiving the at least one drug having anesthetic properties (¶ 0008, claim 1, Fig. 2, step 204, ¶¶s 0023 and 0029, etc.); a processor configured to receive the EEG data and carry out steps (¶ 0008, claim 1) including: fitting the EEG data to a state space model to produce a fitted state space model (¶¶s 0076, 0046, etc., fitting EEG data to a state-space model - also see Fig. 2, step 206, ¶¶s 0082-0085, etc.), wherein fitting the EEG to the state space model comprises fitting to at least one oscillatory component (¶ 0046, α activity - also see ¶¶s 0047, 0049, 0050, etc.); estimating at least one value of cross-frequency coupling of the EEG data … (Fig. 2, step 214, ¶¶s 0047, 0049, 0050, etc., describing phase-amplitude coupling which is a type of cross-frequency coupling (see e.g. ¶ 0050, describing coupling between phase in one frequency and amplitude in another frequency); ¶¶s 0049, 0075, 0076, etc., describe combining phase-amplitude coupling analysis with state-space model analysis, using the state-space model to build a behavioral dynamics model which includes phase-amplitude coupling. Examples of measurement of phase-amplitude (or cross-frequency) coupling enabled by the system are further described in ¶¶s 0091, 0092, etc.); and generating a report in real time (¶ 0090) including information related to a current state of consciousness of the patient based on the at least one value of cross-frequency coupling (Fig. 2, step 216, ¶ 0075); and a display configured to display the report (¶ 0025, the generated report being a real-time display of signature information and determined state, ¶ 0030, “visual representations,” etc.).
Brown’973 does not appear to explicitly teach iteratively expanding the state space model by adding additional oscillatory components until an information criterion indicates a best fit state space model, and estimating at least one value of cross-frequency coupling of the EEG data using the fitted state space model.
Principe teaches applying the Akaike Information Criterion to nested models (built by adding parameters to parent models), including models of different model orders, to select the best model (¶ 0345). It also teaches iteration to find a best fit, including via the Expectation Maximization algorithm (¶¶s 0158, 0345, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to iteratively expand the state space model of Brown’973 by adding additional oscillatory components until the Akaike Information Criterion indicated a best fit state space model, as in Principe (adding parameters to nested models and/or evaluating models of different order), to thereby estimate at least one value of cross-frequency coupling using the fitted model, for the purpose of selecting and using the best performing model (Principe: ¶ 0345).
Regarding claim 12, Brown’973-Principe teaches all the features with respect to claim 11, as outlined above. Brown’973-Principe further teaches wherein the at least one value of cross-frequency coupling comprises an estimated value of phase amplitude modulation between a first wave component and a second wave component included in the state space model (Brown’973: ¶¶s 0047, 0049, etc., phase-amplitude analysis considering the phase of one wave and the amplitude of another wave).
Regarding claims 13 and 14, Brown’973-Principe teaches all the features with respect to claim 12, as outlined above. Brown’973-Principe further teaches wherein the first wave component is a slow wave component and the second wave component is an alpha wave component, wherein the estimated value of phase amplitude modulation is calculated based on a phase of the slow wave component and an amplitude of the alpha wave component (Brown’973: ¶ 0050).
Regarding claim 15, Brown’973-Principe teaches all the features with respect to claim 11, as outlined above. Brown’973-Principe further teaches wherein the at least one value of cross-frequency coupling comprises a correlation value between an oscillatory component included in the state space model and a band of frequencies of the EEG data (Brown’973: ¶ 0049, measuring phase-amplitude coupling - also see ¶ 0047, explaining that phase-amplitude analysis deals with correlations, unlike spectral analysis).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Brown’973-Principe in view of US Patent Application Publication 2014/0323897 (“Brown’897”).
Regarding claim 16, Brown’973-Principe teaches all the features with respect to claim 11, as outlined above. Brown’973-Principe does not appear to explicitly teach wherein the fitting the state space model comprises fitting harmonic frequencies of each oscillatory component included in the at least one oscillatory component.
Brown’897 is in the field of estimating EEG spectrograms to monitor a patient state (Title and Abstract) and teaches fitting harmonic frequencies of each oscillatory component ([0054], 'Using the concepts and models provided above, as applied, for example, to EEG data acquired with a system such as described above, a process for non-parametric spectral analysis for batch time series as a Bayesian estimation problem is provided by introducing prior distributions on the time-frequency plane. As will be described, the process can be used to yield maximum a posteriori (MAP) spectral estimates that are continuous in time yet sparse in frequency. This spectral estimation procedure, termed harmonic pursuit, can be efficiently computed using an iteratively re-weighted least squares (IRLS) algorithm and scales well with typical data lengths'; [0056], 'The simulated data can consist of a 10 Hz oscillation whose amplitude is modulated by a slow 0.04 Hz oscillation, and an exponentially growing 11 Hz oscillation. The former is motivated by the fact that low-frequency (<1 Hz) phase modulates alpha (8-12 Hz) amplitude during profound unconsciousness, and during the transition into and out of unconsciousness, under propofol-induced general anesthesia. The latter can be incorporated to demonstrate the desire, in certain applications, to resolve closely-spaced amplitude-modulated signals'; [0091], 'The harmonic components might also be used as part of an algorithm to estimate phase-amplitude modulation, using the frequencies identified from the harmonic pursuit algorithm, as well as the harmonic amplitudes and phase'; [0107] and Fig. 6A-6D describe examples of actual harmonic frequencies being examined).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate harmonic pursuit in the combination as in Brown’897, for the purpose of inputting the harmonic components to determine a characterization of overall level of anesthesia, summarized by a single scaled number (e.g., an index between 0 and 100)(Brown’897: ¶ 0091)).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Brown’973-Principe in view of non-patent publication Turner, Richard, and Maneesh Sahani. "Probabilistic amplitude and frequency demodulation." Advances in Neural Information Processing Systems 24 (2011) (“Turner”).
Regarding claims 17 and 18, Brown’973-Principe teaches all the features with respect to claim 11, as outlined above. Brown’973-Principe further teaches wherein the at least one oscillatory component includes an alpha component (Brown’973: ¶ 0061, alpha rhythm - also see ¶¶s 0046, 0050, etc.), and the alpha component is associated with prior distribution (Brown’973: ¶ 0088), but does not appear to explicitly teach it being associated with prior distribution for a center frequency, wherein the prior distribution is a Von Mises prior.
Turner is in the field of amplitude and frequency demodulation for neural signal processing applications (bottom of listed pg. 1 in Introduction section) and teaches the alpha component is associated with prior distribution for a center frequency (bottom of listed pg. 1 in Introduction section, 'Aggregate field measurements such as those collected at the scalp by electroencephalography (EEG) or within tissue as local field potentials often exhibit transient sharp spectral lines at characteristic frequencies. Within each such band, both the amplitude of the oscillation and the precise center frequencies may vary with time; and both of these phenomena may reveal important elements of the mechanism by which the field oscillation arises'; middle of listed pg. 4, 'An important initial consideration is whether to use a representation for phase which is wrapped ... lt is therefore necessary to work with wrapped phases and a sensible starting point for a prior is thus the von Mises distribution'; pg. 5 lists equations of the model using alpha components).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the prior distribution processing of Turner in the combination, for the purpose of obtaining a model for natural and synthetic signals that outperforms conventions models (Turner: bottom of listed pg. 8).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Brown’973-Principe in view of non-patent publication Stevenson, Nathan J., et al. "A nonlinear model of newborn EEG with nonstationary inputs." Annals of biomedical engineering 38 (2010): 3010-3021 (“Stevenson”).
Regarding claims 19 and 20, Brown’973-Principe teaches all the features with respect to claim 11, as outlined above. Brown’973-Principe does not appear to explicitly teach wherein a damping factor of the state space model is constrained with a prior distribution, wherein the prior distribution is a beta distribution.
Stevenson is in the field of applying algorithms to EEG signals (Abstract) and teaches wherein a damping factor of a state space model is constrained with a prior distribution (right column of page 3016, 'The distribution of each parameter was modelled with the Beta distribution. [23] We used the Beta distribution as it is a bounded, adaptable distribution that can cope with limits on the EEG signals due to filtering and sampling; left column of page 3017, ‘The joint distribution of the nonlinear spring constant and damping coefficient is shown in Fig. 9(a). The use of joint distributions was necessary as the frequency content of the Duffing oscillator is jointly related to both the effective spring constant and damping value').
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a damping factor constrained by a beta distribution in the combination as in Stevenson, for the purpose of creating a model that can accurately represent the condition being determined from EEG data (Stevenson: pg. 3, 10), the Beta distribution able to cope with limits on EEG signals due to filtering and sampling (Stevenson: right column of page 3016 as above).
Response to Arguments
Applicant’s arguments filed 02/02/2026 have been fully considered.
In response to the arguments and amendments regarding the rejections under 35 USC 101, they are persuasive to the extent that the claims are not directed to a mental process. However, they are still directed to a mathematical concept.
Regarding a practical application, the Office disagrees that the claimed subject matter is directed to an improvement in the functioning of a computer. Even if e.g. ¶¶s 0282 and 0283 (of the specification as filed, or ¶¶s 0294 and 0295 of the specification as published) mention an improvement, that improvement is not reflected in the claims. The claims do not e.g. require phase-amplitude coupling, tracking CFC, a particular window size, etc. The alleged reduction in computing power is also not evident since it is not described in the specification, and there is no consideration of possible extra uses of computing power due to dynamic estimation, etc. And, the improvement would not be in the computer itself but in an algorithm running on the computer (i.e., an improvement in an abstract idea). Further, improvements to certain medical applications are not necessarily described in the speciation (¶ 0283 refers to possible improvements, not actual improvements), and not reflected in the claims (at least because a parametric model of modulation as described in ¶ 0282 is not claimed).
In response to the arguments related to the rejections under 35 USC 103, they are persuasive to the extent that the previous combination was not explicit about using an information criterion to indicate a best fit. Therefore, a new grounds of rejection is made in view of Principe, and all claims remain rejected in light of the prior art.
Conclusion
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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